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Patient Treatment Kit - Hyperthermia system, ultrasound - ARTG 459165

Access comprehensive regulatory information for Patient Treatment Kit - Hyperthermia system, ultrasound in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 459165 and sponsored by Getz Healthcare Pty Ltd, manufactured by InSightec Ltd in Israel. The device registration started on August 09, 2024.

This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.

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Class IIa
ARTG 459165
Class IIa
Patient Treatment Kit - Hyperthermia system, ultrasound
ARTG ID: 459165
Good Name: Getz Healthcare Pty Ltd - Patient Treatment Kit - Hyperthermia system, ultrasound
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Intended Purpose

Accessories to Exablate 4000 system intended to produce and control the delivery of high heat, i.e. temperatures greater than 43 degrees Celsius, to the body for the treatment of malignant or benign tumours, or other disease conditions. It is capable of producing whole body or localized heating effects within tissue or organs using an ultrasonic energy source.

Device Classification
Risk Class
Class IIa
Product Type
Medical device system
ARTG Category
General
Registration Information
ARTG ID
459165
Start Date
August 09, 2024
Effective Date
August 09, 2024
Manufacturer
Country
Israel
Address
5 Nachum Heth St, PO BOX 2059, Tirat Carmel, 39120